Back in 2013, the United States Food and Drug Administration (FDA) announced that the recommended Ambien dosage for women should be halved.
That meant many women who were used to a dosage of 10 mg might only be prescribed 5 mg in the future.
But was that unfair to female insomniacs? Or is it justified considering the alleged increase in the risk of driving accidents in the morning?
To answer these questions, some background to the issue is needed.
The new dosage
The FDA announced that it had told manufacturers of sleeping pills containing Zolpidem, such as Ambien, that they should reduce the recommended dosage.
So the standard Ambien dosage for women was reduced from 10 mg to 5 mg. And for extended release formulations, it was reduced from 12.5 mg to 6.25 mg.
For men, however, the FDA only recommended that doctors consider lowering the dosage to 5 mg and 6.25 mg respectively.
In addition, the FDA added that medical practitioners should advise patients that they are at a higher risk of impaired mental alertness.
Clinical trials showing worse driving skills
The reason behind the change is recent clinical trials and driving simulation studies. They found that some women perform certain tasks, such as driving, less well the morning after taking Ambien.
They found that women eliminate Zolpidem slower than men, though men also have a small chance of driving worse the next morning.
This was widely reported in the news, but what’s particularly interesting is the reaction from many people who rely on such sleeping pills to manage their insomnia.
How high is the risk really?
The comments sections of online news articles show a strong reaction from people who believe that they tolerate their higher Ambien dosage well.
Many people feel they pose no potential threat to others from activities such as driving – especially those that don’t even drive.
Unsurprisingly, the manufacturers of Ambien, Sanofi, also released a statement saying that they believe Ambien to be safe. This is according to their clinical data and 20 years of use by millions of people.
Ambien has indeed had a great deal of testing by people. It’s the most popular sleeping pill available in many countries.
In 2011 in the United States alone, 44.8 million prescriptions were written for sleeping pills containing Zolpidem.
With so much apparently safe usage of the higher Ambien dosage, how bad could the results of these simulation studies have been?
Too much Ambien in the bloodstream the next morning
The driving simulation studies found that if people have over 50 ng/mL Zolpidem in the blood, there’s an increased risk of having a driving accident.
The simulation studies involved 250 men and 250 women taking a dose of 10mg Ambien.
8 hours after dosage, they discovered that 15% of women and 3% of men exceeded the levels of 50 ng/mL. And 4 people had more than 90 ng/mL.
And those who took the extended-release 12.5mg had even higher incidents of elevated Zolpidem amounts in the blood: 33% of women and 25% of men.
Zolpidem-related driving accidents
Interestingly, the FDA says on their website that they have “about 700 reports of zolpidem and impaired driving ability and/or road traffic accident.”
They also say that it was only when they received the data from the driving simulation studies that they took action to reduce the dosage; up until then, it was difficult to work out what role the sleep aid really had in those 700 incidents.
So it seems that the combination of the two pieces of information was key to the decision making, not just the simulation studies.
What the manufacturer of Ambien says
This issue isn’t new news, with the following statement appearing on Sanofi’s website:
Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem
They then go on to say:
Due to the risk to the patient and the community, discontinuation of Ambien CR should be strongly considered for patients who report a “sleep-driving” episode.
So should people be given a chance to continue with the old Ambien dosage and drive responsibly? Or should a potentially life-threatening risk be prevented outright?
Another statement on Sanofi’s website raises another point to consider:
As with “sleep-driving”, patients usually do not remember these events.
So if patients don’t always remember that they were sleep-driving, how can they be expected to report the episode?
Why insomniacs feel it’s unfair
There appear to be several reasons some people feel the change is unfair:
- They feel they shouldn’t be punished because the drug can have dangerous effects on a minority of people.
- The dosage should be tailored to each individual’s needs.
- They believe some people don’t follow the guidance properly – timing, mixing with alcohol etc.
- If they don’t get a good night’s sleep, they are even more at risk of having a driving accident.
- Some people don’t drive anyway, so why should the rule apply to them?
While the frustration of people who Ambien helps sleep is understandable, the risks have to be balanced.
Although the FDA states that only a few dozen incidents of sleep-driving have been reported, they suspect there are many more unreported cases.
Update to the FDA guidance
When this news first broke in 2013, it provoked disappointment and outrage because of the sudden and strict dosage change.
I’ve kept an eye on the guidance over the years, and noticed that it has changed more than once. There was a change at one point to suggest the dosage could be increased again if the lower dosage wasn’t effective.
More recently in 2018, the exact wording on the FDA website has again changed to suggest a more tailored approach based on the individual instead.
Here are some excerpts from the guidance that I think are interesting:
FDA has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses. These lower doses of zolpidem (5 mg for immediate-release products and 6.25 mg for extended-release products) will be effective in most women and many men.
And here is what the advise for people already on a higher dosage:
If you are currently taking the 10 mg or 12.5 mg dose of zolpidem-containing insomnia medicine, continue taking your prescribed dose as directed until you have contacted your health care professional to ask for instructions on how to safely continue to take your medicine. Each patient and situation is unique, and the appropriate dose should be discussed with your health care professional.
They also have this to say concerning the argument about weight and other factors having a role to play:
Based on data from pharmacokinetic trials, no relationship was evident between the zolpidem blood level and patients’ body weight or ethnicity.
If you’d like to keep up to date with any changes to the recommended dosage, you can do so by looking at the website linked above, and also section on Ambien dosage at drugs.com.
Do you find Ambien affects your ability to drive in the morning? Do you feel it was an unfair change in dosage?
Please leave a comment below with your thoughts.